preterm labor assessment toolkit implementation
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PRETERM LABOR ASSESSMENT TOOLKIT IMPLEMENTATION5-2018
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By
For the degree of
DOCTOR OF NURSING PRACTICE
PRETERM LABOR ASSESSMENT TOOLKIT IMPLEMENTATION
This DNP Scholarly Project by Mandi Mae Wilkins is recommended for approval by the
student’s Faculty Chair, Committee and Department Head in the School of Nursing.
Fill in the name
Mandi Mae Wilkins
Every year 10% of babies in the United States are born premature. Prematurity is the
leading cause of infant mortality. Standardized preterm labor (PTL) assessment protocols
reduced preterm birth rates, decreased costs, and resulted in more timely diagnoses and
prevented the overtreatment of pregnant women who were not experiencing true preterm
labor. At a Midwestern, Level II trauma hospital with regional neonatal intensive care
unit and 700 annual deliveries, a Preterm Labor Assessment Toolkit (PLAT) was
implemented and pre- and post-data garnered. The toolkit contained a provider algorithm
and an order set for triaging preterm labor (PTL) patients. Beginning in fall 2015, a chart
audit from a convenience sample of 91 coded threatened PTL patients between 24 and
36.6 weeks’ gestation occurred. Post-implementation data was collected after two years
on 90 patients with the same criteria. Key measures outlined and compared included
disposition to decision times, frequency of sterile speculum and vaginal exams, fetal
fibronectin collection, cervical length measurements, and the use of antenatal steroids and
tocolytic therapies. In comparison to pre-implementation results, post-implementation
findings showed increased numbers of sterile speculum exams, fetal fibronectin
collection, and cervical length measurements. In the sample study, the disposition to
decision time was cut in half and no patients delivered preterm after implementation of
the PLAT protocol.
improvement.
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DEDICATION
This scholarly project is dedicated to my father, who always believed in me and said I
could do anything in life, the support team who helped me stay steadfast through the
hoops, and my husband Michael Wilkins, my sister Brandi McCrum, and a friend and
colleague, Patti Greethurst.
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ACKNOWLEDGMENTS
I wish to thank my preterm labor project partner Erika Osier RN; my project chair
Professor Dr. Jane Campbell; project consultant Maternal Fetal Medicine Specialist Dr.
Michael Ruma; and project readers, professors Michelle Johnson RN, and Dr. Kristi
Robinia.
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PREFACE
Hologic Company, the producer of fetal fibronectin, provided a grant allowing Erika
Osier and I to host a Preterm Labor Toolkit Event held July 11, 2016 at Northern
Michigan University. The company also provided monetary means for us to present at
Henry Ford Hospital and share our research data. Finally, Hologic Company is assisting
us in the publication of a white paper where our case study will be showcased in the Fetal
Fibronectin Handbook.
Appendix A. Figure 2. MOD Preterm Labor Algorithm. ..................................................21
Appendix B. IRB approval UP Health Systems Marquette ...............................................22
Appendix C. Figure 3. Upper Peninsula Regional Hospital and outlying critical care
access facilities..............................................................................................23
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LIST OF TABLES
Table 1. Results of study on maternal admissions and triage time ....................................11
Table 2. Cost savings ..........................................................................................................12
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PTL ................................................................................................................ Preterm Labor
TVUS ............................................................................................. Transvaginal Ultrasound
Chapter One
Clinical Problem
The WHO (World Health Organization) reported over 15 million premature
babies are born across the globe each year (2015). Preterm birth is defined as babies born
alive at or before 36.6 weeks’ gestation of pregnancy, and are further classified as
extremely preterm prior to 28 weeks, very preterm between 28 to 32 weeks, and moderate
to late preterm between 32 to 37 weeks (WHO, 2015). The WHO (2015) stated 75% of
preterm births were preventable with current diagnostic and cost-effective interventions.
The March of Dimes (MOD) found one in 10 deliveries are preterm in the United States
(MOD, 2016). Preterm birth remains constant as one of the leading causes of infant
mortality.
The Centers for Disease Control (CDC) (2017) accounted preterm births are the
greatest cause of infant death, with most demises occurring in babies born at less than 32
weeks’ gestation. As preterm babies survive, this vulnerable population faces many
dangerous and costly health challenges, including respiratory issues from underdeveloped
lungs, feeding difficulties, cerebral palsy, intellectual disabilities, and vision or hearing
impairments (CDC, 2017). Data from the past decade in the Institute of Medicine
Committee on Understanding Premature Birth and Assuring Healthy Outcomes (2007)
estimated at minimum, the cost of preterm birth in the United States is $26 billion dollars
with the average cost at $50,000 for each baby.
According to the Michigan Department of Health and Human Services
(MDHHS), seven out of every 1,000 babies born won’t live to blow out candles on their
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first birthday cake (2012). Of these deaths, the Michigan Infant Mortality Reduction Plan
(MIMRP) found 25% related to premature birth (2012). To address the high infant
mortality rate, the Michigan Department of Community Health (MDCH) collaborated
with the March of Dimes (MOD) and the Michigan Hospital Association (MHA) to
create the MIMRP. The plan aligns with existing policies and health initiatives such as
Healthy Babies are Worth the Wait, a campaign promoted to waiting 39 weeks for
cesareans or inductions (MDHHS, 2012). Strategies encompassed waiting for full term
deliveries, providing progesterone to at-risk mothers, and providing better access to care
and decreasing health disparities. One significant area not addressed in the state plan was
correctly identifying mothers in preterm labor, allowing for the delay or prevention of
preterm births.
Diagnosing and treating threatened PTL (preterm labor) is imperative in
preventing preterm birth, and in preventing unnecessary and costly interventions to
patients. No standardization in care exists in Michigan nor in the United States for the
assessment of threatened PTL patients. Differences in assessment practices result in
adverse outcomes and/or preventable complications for both mothers and babies. A
patient presenting with PTL can go to one hospital for observation and monitoring,
whereas another hospital may use a precise protocol to diagnose PTL. In these cases, if
not diagnosed accurately these women are subjected to numerous costly interventions,
including transfers via ambulance, admission and observation, IV fluids, fetal monitoring,
antenatal corticosteroids, and magnesium therapy. Although some instances of preterm
birth are unavoidable, studies show up to 75% of mothers presenting in threatened PTL
go on to deliver healthy babies at term (March of Dimes, 2016).
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Adopting a PTL assessment protocol can decrease preterm birth rates, improve
outcomes for mothers and babies, and save patients, hospitals, and taxpayers
economically. Standardization of care for preterm labor patients has been very successful
in numerous hospitals across the United States through implementation of protocols such
as the Preterm Labor Toolkit (PLAT), which was advocated for by the March of Dimes at
the time of this research (2016). PLAT consists of an algorithm and protocol of care
measures based on presenting symptoms and health status of the preterm labor patient.
The evidence-based protocol allows a guide for care providers to implement interventions
and diagnostic testing such as sterile speculum exams, fetal fibronectin collection, and
cervical length measurements. At minimum, adoption of fetal fibronectin testing and
cervical length measurements of the protocol require consideration, as these were
identified as predictors associated with impending preterm birth (Bolt et al., 2011).
The purpose of this project and clinical research was to improve healthcare
outcomes within the upper peninsula of Michigan by standardizing care for preterm labor
patients. The goal for implementation of this standardized care model was to decrease
patient transfers from outlying facilities, increase cost savings, and improve overall
patient outcomes for the region.
The Donabedian (1988) theoretical framework for quality of care was a conducive
guide for this project. Addressing quality in this theory occurred by reviewing how well
care was performed, if there were positive outcomes, and monetary effectiveness
(Donabedian, 1988). Statistics of the adherence to the standard protocol, outcomes of
patients including delivered or undelivered status, disposition to decision times, and cost
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savings for decreased length of stays and transfers from outlying facilities were all
examined in this project.
The PLAT set forth a standardized algorithm for providers based on patient
assessment data and specific premade order sets allowing for care interventions (see
Appendix A). Donabedian (1988) placed suppositions in the quality of care into three
categories: structure, process, and outcome. Structure is indicative of the setting in which
care ensues. The project was conducted at a Level III trauma hospital with regional
NICU and resources to implement all components of PLAT. The process represented the
care provided or standardized preterm labor protocols instituted in this case. Finally, for
the Donabedian model, the outcome designated effects of care implemented on the
population, identified in this study as preterm labor patients and their offspring.
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Chapter Two
Literature Review
An extensive literature review was conducted for this project. Search tools
included the Cochrane Library and resources cited from the March of Dimes Preterm
Labor Assessment Toolkit. A search through the Cochrane Library with key words
preterm labor assessment yielded 534 results, which was narrowed down to seven by
choosing pregnancy, childbirth, and prevention subtitles with a back date from 2008.
Results were narrowed to four articles. Pertinent key articles represented in current
literature regarding standardization of preterm labor, fetal fibronectin, and cervical length
measurement were garnered.
Preterm labor and birth place a strain both on the economy and on patients
emotionally. Examined in research were the phenomenon and cause of preterm labor,
while providers tracked risk factors for individual patients and treatment accordingly. A
standardized approach to utilizing the pathophysiology behind PTL and monopolizing on
clues set forth by the human body was attained with current diagnostics and protocols.
Rose (2010) was a cornerstone article for this project and consisted of a 12-month
retrospective observational study at the Mayo Clinic. A protocol similar to the Preterm
Labor Assessment Toolkit was implemented to standardize care of threatened preterm
labor patients. In outcome data for the Rose (2010) study, only three women delivered
within 7 days, out of 201 patients; and the hospital admission rate decreased by over half
in that year, resulting in an annual cost savings of $40,000.
A study by Lucovnik, Chambliss, and Garfield (2013) tracked unnecessary
treatment costs by conducting a chart audit on 12 months’ worth of data from
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hospitalizations for preterm labor at less than 34 weeks’ gestation. Lucovnik et al. (2013)
found hospital costs to be just over one million dollars to manage care for patients who
went on to deliver full term, with the mean patient cost at just over $20,000. The study
concluded futile interventions contributed to the explosion of health care costs and were
preventable through the use of current diagnostic tests and standardized protocols
(Lucovnik, Chambliss, & Garfield, 2013).
Diagnostic tests beneficial in diagnosing preterm labor include (fFN) collection
and cervical length measurements. Fetal fibronectin is a glycoprotein secreted by
chorionic membranes that adhere membranes to the underlying maternal decidua and
indicate preterm labor if found in cervco-vaginal secretions between 24 weeks’ and 34
weeks’ gestation. The fFn test has been in practice for the past 2 decades. Peaceman et
al. (1997) found the test carries a negative predictive value of 99% that a woman will not
deliver within 2 weeks of a negative fFN test.
The Iyer et al. (2012) study conducted by Brigham Women’s and Children’s
Hospital found the implementation and use of fFN alone decreased the hospital’s
unnecessary PTL admissions that resulted in a one million dollar a year cost savings.
Results from a Cochrane systematic review by Bergella (2008) examined five-controlled
studies of nearly 500 pregnant women and found a lack of sufficient evidence to support
or negate the use of the fFN for diagnosing women with PTL. More recently, Blackwell
et al. (2017) completed a retrospective cohort study and analysis using information from
a large insurance claims database containing nearly 23,000 patient charts. Results of the
study found the number of patients who delivered preterm within 3 days of discharge of
OB triage was lower in women who received fFN screening (Blackwell et al., 2017).
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Blackwell et al. (2017) noted of their sample, 20% of patients delivered preterm within 3
days of discharge, and of those patients, only 4% were evaluated with fFN.
Cervical length measurements via ultrasound are another diagnostic tool utilized
for threatened preterm labor patients. A review conducted by Slager and Lynne (2012)
revealed gestational age is a predictor of preterm labor and subsequent birth. Slager and
Lynne (2012) found women with cervixes less than 25mm had nearly a 45% risk of
giving birth within the following 7 days. In contrast, Berghella, Baxter, and Henrix
(2013) provided an additional review of literature and noted a lack of sufficient evidence
to recommend routine CL screening in pregnancy.
As utilized in the PLAT algorithm for this study, evidence based research shows
that combining the use of the fFN test and CL measurement provides the most accurate
diagnosis. DeFranco, Lewis, and Odibo (2013) stressed the importance of concurrently
using the fFN test and CL measurement in a systematic research analysis and explained
the combined effect had a negative predictive value of 93%. McCue and Torbenson
(2017) revealed fFN elicited cost savings by ruling out patients with false labor, and
when used concurrently, the positive predictive value increased to 45%. A cost-
effectiveness study on these two diagnostic tests was conducted by Van Baaren et al.
(2013) in The Netherlands. Results of the study, found by triaging PTL patients with a
CL measurement less than threshold and combining fFN testing, indicated accrued
savings were between $3 and $14 million (EUR) annually on the unnecessary treatment
of women not in true PTL.
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Methodology
In October 2015, the March of Dimes Preterm Labor Assessment Toolkit was
implemented at a Level III hospital in the upper peninsula of Michigan, with a regional
NICU having 700 annual deliveries. Institutional Review Board approval was obtained
for the project (see Appendix B). The regional hospital cares for all area high risk
obstetrical patients and receives transfers from outlying facilities on a regular basis (see
Appendix C). A majority of these patients are eventually discharged home undelivered
after receiving multiple costly interventions and a 1 to 2 day hospital stay.
The PLAT algorithm was initiated to standardize care, improve patient outcomes
with shorter disposition to decision times, and enable cost-effectiveness in treating
threatened preterm labor patients for the hospital. Provider buy in was obtained via
informational meetings and staff education was executed. Specific order sets were put in
place for PTL patients, including having fFN at the top of the set for alerting providers to
obtain this key measure first. fFN must be collected prior to a sterile vaginal exam with
gel that can give false positive results, and be obtained via cervical secretions therefore
requiring a sterile speculum exam.
The algorithm (see Appendix A) utilized a specific protocol for triaging PTL
patients based on gestational age and presenting condition. If adhered to, any patients
with no amniotic rupture that were between 24 and 34 weeks gestation had a fetal
fibronectin obtained via a sterile speculum exam. In addition, a sterile vaginal exam
would be performed to ensure the patient was not dilated past 2 cm. Finally, a
transvaginal ultrasound would then be conducted to measure the cervical length. If found
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to be greater than 25 mm and the fetal fibronectin negative with no cervical dilation
>2cm, than patients were placed in a low risk category for PTB and could be discharged
home. If patients were found to be at a high risk for PTB, than appropriate interventions
were given including tocolytics to relax the uterus from contracting and corticosteroid
therapy to improve lung maturity.
The retrospective cohort study compared a convenience sample of 90 preterm
labor patients in the 2 years prior to implementation, with a convenience sample of 91
patients in the 2 years following implementation. Patient selection occurred using ICD 9
and ICD 10 codes indicating threatened preterm labor and individuals were between
gestational ages of 24 and 36.6 weeks, respectively. Charts were analyzed and
anonymous patient data were input into the March of Dimes PLAT Chart Audit Tool.
Data included specific outcome measures and clinical decision points of the PLAT
algorithm and protocol. Nominal and scale statistics comprised:
• Gestational Age
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Findings from these specific data for both pre-implementation data and post-
implementation data were compared. Statistical analyses occurred using SPSS Statistics
2017 software to ascertain the significance of different diagnostic tests, including fFn,
and transvaginal ultrasound. Transfer patient data were analyzed for frequency, length of
stay, and overall outcomes of delivery or discharge. A major basis for analyzing data
was the disposition to decision, or triage times after implementation of the protocol.
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Chapter Four
Project Analysis
In reviewing results of the study and reflecting on the guidance of the Donabedian
Model (see Figure 1), findings were positive in effect of the implementation of a
standardized protocol. The structure or algorithm allowed for triage time from
disposition to decision to reduce by 50%, saving both time and resources. Clinical
decision points and diagnostics completed in the process increased by 10% in post-
implementation data to allow more competence in decision-making. By utilizing the
protocol, the overall outcome was this regional obstetrical unit became more efficient in
diagnosing and treating preterm labor, meeting the goal to improve patient outcomes and
decrease unnecessary costs.
Results
Compared in the study were 2 years’ pre-implementation with 2 years’ post-
implementation data from the implementation of the PLAT with standardized algorithm
for the treatment of PTL patients. The sample of patients included women of
childbearing age who resided in the upper peninsula of Michigan, a rural underserved
area of roughly 300,000 residents. Patients in the sample size were between 24 and 36.6
weeks’ gestational age (GA), with the average GA at 32 weeks. Criteria for the sample
included patients identified with ICD-9 and ICD-10 codes for preterm labor or threatened
preterm labor.
Results of study on maternal admissions and triage time
Of 181 patients evaluated, 11 in the pre-implementation group delivered preterm, and
zero patients in the post-implementation group delivered preterm at that visit. After
implementation of the protocol, the average time in triage from disposition to decision
was decreased by nearly half from 5 hours post-implementation to 2.6 hours pre-
implementation (95% confidence interval [CI], Pvalue= 0.013). This resulted in a
calculated estimated savings of $340,000 in triage costs in the post-implementation
sample.
Compared to pre-implementation data and removing transfer patients who were
automatically admitted, results showed maternal hospital admissions decreased by 78%
(nine versus two patients). A length of stay for admission with preterm labor was on
average 3 days long. This reduction in admissions brought about savings of
approximately $150,000 in the post-implementation sample.
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Table 2
Cost Savings
All clinical decision points increased with the use of the standardized algorithm. Sterile
speculum exams with fFN collection in the post-implantation group increased by nearly
20%. Transvaginal ultrasounds doubled, adding to the level of competency and
assurance in positive predictive value of the diagnosis. Tocolysis increased by 10% and
AS increased in patients admitted.
Figure 1. Results of descriptive data in percentages
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Transfer patient outcomes improved with 29 patient transfers sent home
undelivered in the post-implementation study sample, compared to the pre-
implementation sample where six patient transfers (out of 22) delivered preterm.
Transfer patients in the area can be problematic for the regional unit as these patients
utilize resources including transportation via ambulance, costly interventions, and
automatic admission. At UPHS Marquette, the average outpatient cost is $3,000,
whereas a transfer patient admission can cost as much as $17,000 after a 3-night stay with
medical interventions. The hospital is currently identifying ways to decrease unnecessary
transfers by instituting the PLAT protocol or at minimum the fFN collection at outlying
sending facilities.
Conclusion
This was the first study with the focus on evaluating the effectiveness of a
standardized algorithm for triaging preterm labor patients in the upper peninsula of
Michigan. Examined in the retrospective study were 90 pre-implementation preterm
labor patient charts in the 2 years preceding with 91 post-implementation charts in the 2
years after initiation of the protocol. The use of an evidence-based standardized
algorithm in triaging PTL patients was effective in both improving patient outcomes and
in decreasing costs. Hospital admissions decreased by 78%, which resulted in an
estimated $150,000 cost savings. The time of disposition to decision, or time in triage,
decreased from approximately 5 hours to 2.6 hours. This accounted for an estimated
$340,000 in cost savings. When coupled with admission savings, the result was nearly
$500,000 in savings for the hospital over a 2-year period in only a small sample of
patients.
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Patient outcomes improved reflective with less time in triage by a disposition and
diagnosis made quicker with standardized evidence-based diagnostic testing, allowing for
peace of mind. Of patients admitted for preterm labor in post-implementation data, all
were discharged home undelivered from that visit. This included transfer patients sent
from outlying facilities who were automatic admissions with 3-day stays.
Hospitals across the United States can synthesize research included in this study
and others such as the Rose (2010) study at the Mayo Clinic. Outcomes of both studies
provided strong evidence a standardized algorithm for triaging PTL patients improves
patient outcomes and decreases unnecessary costs to hospitals. Preterm births are the
number one cause of infant deaths across the United States and the world. Consistent
implementation of evidence-based protocols such as PLAT can improve patient outcomes
for this population.
It is imperative all healthcare agencies have collaboration, commitments, and
cooperation from administration, physicians, multidiscipline teams, and nurses to
implement standardized algorithms for improved patient outcomes and to become more
fiscally responsible in accruing unnecessary healthcare costs. Next steps should address
implementing a national standardized algorithm that tailored to facilities based on their
resources. Strategies to attain this would involve the comprehensive approach and
advocacy of dedicated individuals to highlight benefits from the latest research such as
this study to national audiences, including government health committees. In the future,
hospitals across the United States should adopt and personalize a standardized algorithm
to triage preterm labor patients efficiently for improved patient outcomes.
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Limitations to the study included the convenience sample of patients. A
limitation in this study was patients were coded with specific ICD-9 and 10 codes for
preterm and threatened preterm labor. The limitation identified in data collection was
that some patients were coded incorrectly and were not preterm labor patients; such
patients were removed from the study. Another limitation to the convenience sample was
transfer patients. Due to the automatic admission and nature of treatment, transfer
patients skewed data from admissions. To garner a true admission percentage, transfer
patients were excluded from the number of admissions.
A final limitation to the study was that transvaginal ultrasounds increased two-
fold and this had the potential to decrease cost savings. Transvaginal ultrasounds can
cost $1,000-$3,000. Even with this limitation, savings to the hospital were identified and
rather remarkable at nearly half a million dollars in 2 years on a fraction of patients
triaged. The clinical measure of transvaginal ultrasound with cervical length allowed
overall for a more definitive diagnosis and discharge sooner for patients, which may
offset the extra cost.
Aside from study limitations, results of this research provided positive assurance
in the effectiveness of a standardized algorithm for PTL patient triage moving forward.
The outcome for patients to have peace of mind with swifter diagnoses and either
discharge or admission and treatment is imperative. Future studies can assess and
measure this qualitative data behind standardized protocols from the patient’s point of
view and experience.
After implementation of the standardized PTL algorithm, patients were triaged faster
and subsequently discharged sooner receiving fewer unnecessary costly interventions if
not high risk for PTB. Patients identified in PTL received treatment earlier to have better
outcomes by stopping or slowing the progression of labor and allowing antenatal
corticosteroid (AS) treatment. The correct timing of AS within 1 week of delivery was
key to their benefit in allowing for fetal lung maturity. Results from a study conducted
by Adams, Kinzler, Chavez, and Vintzileos (2015) revealed 80% of the time patients
receive AS at suboptimal timing. Utilizing evidence-based standardized algorithms, such
as PLAT, increased the potential to improve the timing of AS and the outcomes for
preterm babies.
In the post-implementation group, no preterm deliveries were noted at hospital
visits and all admitted patients were discharged home undelivered. Studies such as Rose
(2010) tracked patients sent home undelivered to assess if they went on to deliver at term.
This was efficient in analyzing the true outcomes of these mothers. In future studies, end
outcomes of the PTL patients can be measured to assess the validity of the
standardization further. For this study, in the immediate triage visit, optimal outcomes
were found including decreased disposition to decision times and less maternal
admissions with resultant increased cost savings. Although preterm birth at times can be
inevitable, in cases where a standardized protocol is followed to diagnose and treat,
improved outcomes are possible in this population.
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References
Adams, T. M., Kinzler, W. L., Chavez, M. R., & Vintzileos, A. M. (2015). The timing of
administration of antenatal corticosteroids in women with indicated preterm birth.
American Journal of Obstetrics and Gynecology, 212(5), 645. e1-4.
https://doi.org/10.1016/j.ajog.2014.11.021
Berghella, V., Hayes, E., Visintine, J., & Baxter, J. K. (2008). Fetal fibronectin testing for
reducing the risk of preterm birth. The Cochrane database of systematic reviews,
(4), CD006843. https://doi.org/10.1002/14651858.CD006843.pub2
Berghella, V., Baxter, J. K., & Hendrix, N. W. (2013). Cervical assessment by ultrasound
for preventing preterm delivery. In Cochrane database of systematic reviews.
John Wiley & Sons, Ltd. Retrieved from
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007235.pub3/abstract
Blackwell, S. C., Sullivan, E. M., Petrilla, A. A., Shen, X., Troeger, K. A., & Byrne, J. D.
(2017). Utilization of fetal fibronectin testing and pregnancy outcomes among
women with symptoms of preterm labor. ClinicoEconomics and Outcomes
Research: CEOR, 9, 585–594. https://doi.org/10.2147/CEOR.S141061
Bolt, L. A., Chandiramani, M., De Greeff, A., Seed, P. T., Kurtzman, J., & Shennan, A.
H. (2011). The value of combined cervical length measurement and fetal
fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk
women. The Journal of Maternal-Fetal & Neonatal Medicine, 24(7), 928–932.
https://doi.org/10.3109/14767058.2010.535872
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Preterm Birth | Maternal and Infant Health | Reproductive Health | CDC. (2017,
December 4). Retrieved April 10, 2018, from
https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm
DeFranco, E. A., Lewis, D. F., & Odibo, A. O. (2013). Improving the screening accuracy
for preterm labor: Is the combination of fetal fibronectin and cervical length in
symptomatic patients a useful predictor of preterm birth? A systematic review.
American Journal of Obstetrics and Gynecology, 208(3), 233. e1-233.e6.
https://doi.org/10.1016/j.ajog.2012.12.015
Institute of Medicine (US) Committee on understanding premature birth and assuring
healthy outcomes. (2007). Preterm Birth: Causes, Consequences, and Prevention.
(R. E. Behrman & A. S. Butler, Eds.). Washington (DC): National Academies
Press (US). Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK11362/
Iyer, S., McElrath, T., Jarolim, P., & Greenberg, J. (2013). The association of fFN testing
on hospital admissions for preterm labor. Open Journal of Obstetrics and
Gynecology, 03(01), 126. https://doi.org/10.4236/ojog.2013.31024
Lucovnik, M., Chambliss, L. R., & Garfield, R. E. (2013). Costs of unnecessary
admissions and treatments for “threatened preterm labor.” American Journal of
Obstetrics and Gynecology, 209(3), 217. e1-217.e3.
https://doi.org/10.1016/j.ajog.2013.06.046
March of Dimes. (2016). Preterm labor assessment toolkit | March of Dimes. Retrieved
from http://www.marchofdimes.org/professionals/preterm-labor-assessment-
toolkit.aspx
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McCue, B., & Torbenson, V. E. (2017, September 15). Fetal fibronectin: The benefits of
a high negative predictive value in management of preterm labor. Retrieved from
http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/fetal-
fibronectin-benefits-high-negative-predictive-value-management-preterm-labor
Michigan Department of Health and Human Services [MDHHS]. (2012). Michigan
focuses on reducing premature births to improve infant mortality rates. Retrieved
from http://www.michigan.gov/mdhhs/0,5885,7-339--289859--,00.html
https://www.michigan.gov/documents/mdch/MichiganIMReductionPlan_393783_
7.pdf
Peaceman, A. M., Andrews, W. W., Thorp, J. M., Cliver, S. P., Lukes, A., Iams, J. D., …
Pietrantoni, M. (1997). Fetal fibronectin as a predictor of preterm birth in patients
with symptoms: a multicenter trial. American Journal of Obstetrics and
Gynecology, 177(1), 13–18.
Rose, C. H., McWeeney, D. T., Brost, B. C., Davies, N. P., & Watson, W. J. (2010).
Cost-effective standardization of preterm labor evaluation. American Journal of
Obstetrics & Gynecology, 203(3), 250.e1-250.e5.
https://doi.org/10.1016/j.ajog.2010.06.037
Slager, J., & Lynne, S. (2012). Assessment of cervical length and the relationship
between short cervix and preterm birth. Journal of Midwifery & Women’s Health,
57(Supplment 1), S4-11. https://doi.org/10.1111/j.1542-2011.2012.00209.x
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Van Baaren, G. J., Vis, J. Y., Grobman, W. A., Bossuyt, P. M., Opmeer, B. C., & Mol, B.
W. (2013). Cost-effectiveness analysis of cervical length measurement and
fibronectin testing in women with threatened preterm labor. American Journal of
Obstetrics and Gynecology, 209(5), 436. e1-8.
https://doi.org/10.1016/j.ajog.2013.06.029
http://www.who.int/mediacentre/factsheets/fs363/en/
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Figure. March of Dimes Preterm Labor Assessment Toolkit Algorithm (2010)
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Figure. Upper Peninsula Regional Hospital and outlying critical care access facilities
Northern Michigan University
Mandi Wilkins
Recommended Citation
Follow this and additional works at: https://commons.nmu.edu/dnp
Part of the Maternal, Child Health and Neonatal Nursing Commons
This Scholarly Project is brought to you for free and open access by the Student Works at NMU Commons. It has been accepted for inclusion in DNP Scholarly Projects by an authorized administrator of NMU Commons. For more information, please contact [email protected],[email protected].
Recommended Citation Wilkins, Mandi, "PRETERM LABOR ASSESSMENT TOOLKIT IMPLEMENTATION" (2018). DNP Scholarly Projects. 4. https://commons.nmu.edu/dnp/4
By
For the degree of
DOCTOR OF NURSING PRACTICE
PRETERM LABOR ASSESSMENT TOOLKIT IMPLEMENTATION
This DNP Scholarly Project by Mandi Mae Wilkins is recommended for approval by the
student’s Faculty Chair, Committee and Department Head in the School of Nursing.
Fill in the name
Mandi Mae Wilkins
Every year 10% of babies in the United States are born premature. Prematurity is the
leading cause of infant mortality. Standardized preterm labor (PTL) assessment protocols
reduced preterm birth rates, decreased costs, and resulted in more timely diagnoses and
prevented the overtreatment of pregnant women who were not experiencing true preterm
labor. At a Midwestern, Level II trauma hospital with regional neonatal intensive care
unit and 700 annual deliveries, a Preterm Labor Assessment Toolkit (PLAT) was
implemented and pre- and post-data garnered. The toolkit contained a provider algorithm
and an order set for triaging preterm labor (PTL) patients. Beginning in fall 2015, a chart
audit from a convenience sample of 91 coded threatened PTL patients between 24 and
36.6 weeks’ gestation occurred. Post-implementation data was collected after two years
on 90 patients with the same criteria. Key measures outlined and compared included
disposition to decision times, frequency of sterile speculum and vaginal exams, fetal
fibronectin collection, cervical length measurements, and the use of antenatal steroids and
tocolytic therapies. In comparison to pre-implementation results, post-implementation
findings showed increased numbers of sterile speculum exams, fetal fibronectin
collection, and cervical length measurements. In the sample study, the disposition to
decision time was cut in half and no patients delivered preterm after implementation of
the PLAT protocol.
improvement.
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DEDICATION
This scholarly project is dedicated to my father, who always believed in me and said I
could do anything in life, the support team who helped me stay steadfast through the
hoops, and my husband Michael Wilkins, my sister Brandi McCrum, and a friend and
colleague, Patti Greethurst.
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ACKNOWLEDGMENTS
I wish to thank my preterm labor project partner Erika Osier RN; my project chair
Professor Dr. Jane Campbell; project consultant Maternal Fetal Medicine Specialist Dr.
Michael Ruma; and project readers, professors Michelle Johnson RN, and Dr. Kristi
Robinia.
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PREFACE
Hologic Company, the producer of fetal fibronectin, provided a grant allowing Erika
Osier and I to host a Preterm Labor Toolkit Event held July 11, 2016 at Northern
Michigan University. The company also provided monetary means for us to present at
Henry Ford Hospital and share our research data. Finally, Hologic Company is assisting
us in the publication of a white paper where our case study will be showcased in the Fetal
Fibronectin Handbook.
Appendix A. Figure 2. MOD Preterm Labor Algorithm. ..................................................21
Appendix B. IRB approval UP Health Systems Marquette ...............................................22
Appendix C. Figure 3. Upper Peninsula Regional Hospital and outlying critical care
access facilities..............................................................................................23
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LIST OF TABLES
Table 1. Results of study on maternal admissions and triage time ....................................11
Table 2. Cost savings ..........................................................................................................12
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PTL ................................................................................................................ Preterm Labor
TVUS ............................................................................................. Transvaginal Ultrasound
Chapter One
Clinical Problem
The WHO (World Health Organization) reported over 15 million premature
babies are born across the globe each year (2015). Preterm birth is defined as babies born
alive at or before 36.6 weeks’ gestation of pregnancy, and are further classified as
extremely preterm prior to 28 weeks, very preterm between 28 to 32 weeks, and moderate
to late preterm between 32 to 37 weeks (WHO, 2015). The WHO (2015) stated 75% of
preterm births were preventable with current diagnostic and cost-effective interventions.
The March of Dimes (MOD) found one in 10 deliveries are preterm in the United States
(MOD, 2016). Preterm birth remains constant as one of the leading causes of infant
mortality.
The Centers for Disease Control (CDC) (2017) accounted preterm births are the
greatest cause of infant death, with most demises occurring in babies born at less than 32
weeks’ gestation. As preterm babies survive, this vulnerable population faces many
dangerous and costly health challenges, including respiratory issues from underdeveloped
lungs, feeding difficulties, cerebral palsy, intellectual disabilities, and vision or hearing
impairments (CDC, 2017). Data from the past decade in the Institute of Medicine
Committee on Understanding Premature Birth and Assuring Healthy Outcomes (2007)
estimated at minimum, the cost of preterm birth in the United States is $26 billion dollars
with the average cost at $50,000 for each baby.
According to the Michigan Department of Health and Human Services
(MDHHS), seven out of every 1,000 babies born won’t live to blow out candles on their
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first birthday cake (2012). Of these deaths, the Michigan Infant Mortality Reduction Plan
(MIMRP) found 25% related to premature birth (2012). To address the high infant
mortality rate, the Michigan Department of Community Health (MDCH) collaborated
with the March of Dimes (MOD) and the Michigan Hospital Association (MHA) to
create the MIMRP. The plan aligns with existing policies and health initiatives such as
Healthy Babies are Worth the Wait, a campaign promoted to waiting 39 weeks for
cesareans or inductions (MDHHS, 2012). Strategies encompassed waiting for full term
deliveries, providing progesterone to at-risk mothers, and providing better access to care
and decreasing health disparities. One significant area not addressed in the state plan was
correctly identifying mothers in preterm labor, allowing for the delay or prevention of
preterm births.
Diagnosing and treating threatened PTL (preterm labor) is imperative in
preventing preterm birth, and in preventing unnecessary and costly interventions to
patients. No standardization in care exists in Michigan nor in the United States for the
assessment of threatened PTL patients. Differences in assessment practices result in
adverse outcomes and/or preventable complications for both mothers and babies. A
patient presenting with PTL can go to one hospital for observation and monitoring,
whereas another hospital may use a precise protocol to diagnose PTL. In these cases, if
not diagnosed accurately these women are subjected to numerous costly interventions,
including transfers via ambulance, admission and observation, IV fluids, fetal monitoring,
antenatal corticosteroids, and magnesium therapy. Although some instances of preterm
birth are unavoidable, studies show up to 75% of mothers presenting in threatened PTL
go on to deliver healthy babies at term (March of Dimes, 2016).
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Adopting a PTL assessment protocol can decrease preterm birth rates, improve
outcomes for mothers and babies, and save patients, hospitals, and taxpayers
economically. Standardization of care for preterm labor patients has been very successful
in numerous hospitals across the United States through implementation of protocols such
as the Preterm Labor Toolkit (PLAT), which was advocated for by the March of Dimes at
the time of this research (2016). PLAT consists of an algorithm and protocol of care
measures based on presenting symptoms and health status of the preterm labor patient.
The evidence-based protocol allows a guide for care providers to implement interventions
and diagnostic testing such as sterile speculum exams, fetal fibronectin collection, and
cervical length measurements. At minimum, adoption of fetal fibronectin testing and
cervical length measurements of the protocol require consideration, as these were
identified as predictors associated with impending preterm birth (Bolt et al., 2011).
The purpose of this project and clinical research was to improve healthcare
outcomes within the upper peninsula of Michigan by standardizing care for preterm labor
patients. The goal for implementation of this standardized care model was to decrease
patient transfers from outlying facilities, increase cost savings, and improve overall
patient outcomes for the region.
The Donabedian (1988) theoretical framework for quality of care was a conducive
guide for this project. Addressing quality in this theory occurred by reviewing how well
care was performed, if there were positive outcomes, and monetary effectiveness
(Donabedian, 1988). Statistics of the adherence to the standard protocol, outcomes of
patients including delivered or undelivered status, disposition to decision times, and cost
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savings for decreased length of stays and transfers from outlying facilities were all
examined in this project.
The PLAT set forth a standardized algorithm for providers based on patient
assessment data and specific premade order sets allowing for care interventions (see
Appendix A). Donabedian (1988) placed suppositions in the quality of care into three
categories: structure, process, and outcome. Structure is indicative of the setting in which
care ensues. The project was conducted at a Level III trauma hospital with regional
NICU and resources to implement all components of PLAT. The process represented the
care provided or standardized preterm labor protocols instituted in this case. Finally, for
the Donabedian model, the outcome designated effects of care implemented on the
population, identified in this study as preterm labor patients and their offspring.
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Chapter Two
Literature Review
An extensive literature review was conducted for this project. Search tools
included the Cochrane Library and resources cited from the March of Dimes Preterm
Labor Assessment Toolkit. A search through the Cochrane Library with key words
preterm labor assessment yielded 534 results, which was narrowed down to seven by
choosing pregnancy, childbirth, and prevention subtitles with a back date from 2008.
Results were narrowed to four articles. Pertinent key articles represented in current
literature regarding standardization of preterm labor, fetal fibronectin, and cervical length
measurement were garnered.
Preterm labor and birth place a strain both on the economy and on patients
emotionally. Examined in research were the phenomenon and cause of preterm labor,
while providers tracked risk factors for individual patients and treatment accordingly. A
standardized approach to utilizing the pathophysiology behind PTL and monopolizing on
clues set forth by the human body was attained with current diagnostics and protocols.
Rose (2010) was a cornerstone article for this project and consisted of a 12-month
retrospective observational study at the Mayo Clinic. A protocol similar to the Preterm
Labor Assessment Toolkit was implemented to standardize care of threatened preterm
labor patients. In outcome data for the Rose (2010) study, only three women delivered
within 7 days, out of 201 patients; and the hospital admission rate decreased by over half
in that year, resulting in an annual cost savings of $40,000.
A study by Lucovnik, Chambliss, and Garfield (2013) tracked unnecessary
treatment costs by conducting a chart audit on 12 months’ worth of data from
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hospitalizations for preterm labor at less than 34 weeks’ gestation. Lucovnik et al. (2013)
found hospital costs to be just over one million dollars to manage care for patients who
went on to deliver full term, with the mean patient cost at just over $20,000. The study
concluded futile interventions contributed to the explosion of health care costs and were
preventable through the use of current diagnostic tests and standardized protocols
(Lucovnik, Chambliss, & Garfield, 2013).
Diagnostic tests beneficial in diagnosing preterm labor include (fFN) collection
and cervical length measurements. Fetal fibronectin is a glycoprotein secreted by
chorionic membranes that adhere membranes to the underlying maternal decidua and
indicate preterm labor if found in cervco-vaginal secretions between 24 weeks’ and 34
weeks’ gestation. The fFn test has been in practice for the past 2 decades. Peaceman et
al. (1997) found the test carries a negative predictive value of 99% that a woman will not
deliver within 2 weeks of a negative fFN test.
The Iyer et al. (2012) study conducted by Brigham Women’s and Children’s
Hospital found the implementation and use of fFN alone decreased the hospital’s
unnecessary PTL admissions that resulted in a one million dollar a year cost savings.
Results from a Cochrane systematic review by Bergella (2008) examined five-controlled
studies of nearly 500 pregnant women and found a lack of sufficient evidence to support
or negate the use of the fFN for diagnosing women with PTL. More recently, Blackwell
et al. (2017) completed a retrospective cohort study and analysis using information from
a large insurance claims database containing nearly 23,000 patient charts. Results of the
study found the number of patients who delivered preterm within 3 days of discharge of
OB triage was lower in women who received fFN screening (Blackwell et al., 2017).
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Blackwell et al. (2017) noted of their sample, 20% of patients delivered preterm within 3
days of discharge, and of those patients, only 4% were evaluated with fFN.
Cervical length measurements via ultrasound are another diagnostic tool utilized
for threatened preterm labor patients. A review conducted by Slager and Lynne (2012)
revealed gestational age is a predictor of preterm labor and subsequent birth. Slager and
Lynne (2012) found women with cervixes less than 25mm had nearly a 45% risk of
giving birth within the following 7 days. In contrast, Berghella, Baxter, and Henrix
(2013) provided an additional review of literature and noted a lack of sufficient evidence
to recommend routine CL screening in pregnancy.
As utilized in the PLAT algorithm for this study, evidence based research shows
that combining the use of the fFN test and CL measurement provides the most accurate
diagnosis. DeFranco, Lewis, and Odibo (2013) stressed the importance of concurrently
using the fFN test and CL measurement in a systematic research analysis and explained
the combined effect had a negative predictive value of 93%. McCue and Torbenson
(2017) revealed fFN elicited cost savings by ruling out patients with false labor, and
when used concurrently, the positive predictive value increased to 45%. A cost-
effectiveness study on these two diagnostic tests was conducted by Van Baaren et al.
(2013) in The Netherlands. Results of the study, found by triaging PTL patients with a
CL measurement less than threshold and combining fFN testing, indicated accrued
savings were between $3 and $14 million (EUR) annually on the unnecessary treatment
of women not in true PTL.
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Methodology
In October 2015, the March of Dimes Preterm Labor Assessment Toolkit was
implemented at a Level III hospital in the upper peninsula of Michigan, with a regional
NICU having 700 annual deliveries. Institutional Review Board approval was obtained
for the project (see Appendix B). The regional hospital cares for all area high risk
obstetrical patients and receives transfers from outlying facilities on a regular basis (see
Appendix C). A majority of these patients are eventually discharged home undelivered
after receiving multiple costly interventions and a 1 to 2 day hospital stay.
The PLAT algorithm was initiated to standardize care, improve patient outcomes
with shorter disposition to decision times, and enable cost-effectiveness in treating
threatened preterm labor patients for the hospital. Provider buy in was obtained via
informational meetings and staff education was executed. Specific order sets were put in
place for PTL patients, including having fFN at the top of the set for alerting providers to
obtain this key measure first. fFN must be collected prior to a sterile vaginal exam with
gel that can give false positive results, and be obtained via cervical secretions therefore
requiring a sterile speculum exam.
The algorithm (see Appendix A) utilized a specific protocol for triaging PTL
patients based on gestational age and presenting condition. If adhered to, any patients
with no amniotic rupture that were between 24 and 34 weeks gestation had a fetal
fibronectin obtained via a sterile speculum exam. In addition, a sterile vaginal exam
would be performed to ensure the patient was not dilated past 2 cm. Finally, a
transvaginal ultrasound would then be conducted to measure the cervical length. If found
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to be greater than 25 mm and the fetal fibronectin negative with no cervical dilation
>2cm, than patients were placed in a low risk category for PTB and could be discharged
home. If patients were found to be at a high risk for PTB, than appropriate interventions
were given including tocolytics to relax the uterus from contracting and corticosteroid
therapy to improve lung maturity.
The retrospective cohort study compared a convenience sample of 90 preterm
labor patients in the 2 years prior to implementation, with a convenience sample of 91
patients in the 2 years following implementation. Patient selection occurred using ICD 9
and ICD 10 codes indicating threatened preterm labor and individuals were between
gestational ages of 24 and 36.6 weeks, respectively. Charts were analyzed and
anonymous patient data were input into the March of Dimes PLAT Chart Audit Tool.
Data included specific outcome measures and clinical decision points of the PLAT
algorithm and protocol. Nominal and scale statistics comprised:
• Gestational Age
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Findings from these specific data for both pre-implementation data and post-
implementation data were compared. Statistical analyses occurred using SPSS Statistics
2017 software to ascertain the significance of different diagnostic tests, including fFn,
and transvaginal ultrasound. Transfer patient data were analyzed for frequency, length of
stay, and overall outcomes of delivery or discharge. A major basis for analyzing data
was the disposition to decision, or triage times after implementation of the protocol.
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Chapter Four
Project Analysis
In reviewing results of the study and reflecting on the guidance of the Donabedian
Model (see Figure 1), findings were positive in effect of the implementation of a
standardized protocol. The structure or algorithm allowed for triage time from
disposition to decision to reduce by 50%, saving both time and resources. Clinical
decision points and diagnostics completed in the process increased by 10% in post-
implementation data to allow more competence in decision-making. By utilizing the
protocol, the overall outcome was this regional obstetrical unit became more efficient in
diagnosing and treating preterm labor, meeting the goal to improve patient outcomes and
decrease unnecessary costs.
Results
Compared in the study were 2 years’ pre-implementation with 2 years’ post-
implementation data from the implementation of the PLAT with standardized algorithm
for the treatment of PTL patients. The sample of patients included women of
childbearing age who resided in the upper peninsula of Michigan, a rural underserved
area of roughly 300,000 residents. Patients in the sample size were between 24 and 36.6
weeks’ gestational age (GA), with the average GA at 32 weeks. Criteria for the sample
included patients identified with ICD-9 and ICD-10 codes for preterm labor or threatened
preterm labor.
Results of study on maternal admissions and triage time
Of 181 patients evaluated, 11 in the pre-implementation group delivered preterm, and
zero patients in the post-implementation group delivered preterm at that visit. After
implementation of the protocol, the average time in triage from disposition to decision
was decreased by nearly half from 5 hours post-implementation to 2.6 hours pre-
implementation (95% confidence interval [CI], Pvalue= 0.013). This resulted in a
calculated estimated savings of $340,000 in triage costs in the post-implementation
sample.
Compared to pre-implementation data and removing transfer patients who were
automatically admitted, results showed maternal hospital admissions decreased by 78%
(nine versus two patients). A length of stay for admission with preterm labor was on
average 3 days long. This reduction in admissions brought about savings of
approximately $150,000 in the post-implementation sample.
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Table 2
Cost Savings
All clinical decision points increased with the use of the standardized algorithm. Sterile
speculum exams with fFN collection in the post-implantation group increased by nearly
20%. Transvaginal ultrasounds doubled, adding to the level of competency and
assurance in positive predictive value of the diagnosis. Tocolysis increased by 10% and
AS increased in patients admitted.
Figure 1. Results of descriptive data in percentages
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Transfer patient outcomes improved with 29 patient transfers sent home
undelivered in the post-implementation study sample, compared to the pre-
implementation sample where six patient transfers (out of 22) delivered preterm.
Transfer patients in the area can be problematic for the regional unit as these patients
utilize resources including transportation via ambulance, costly interventions, and
automatic admission. At UPHS Marquette, the average outpatient cost is $3,000,
whereas a transfer patient admission can cost as much as $17,000 after a 3-night stay with
medical interventions. The hospital is currently identifying ways to decrease unnecessary
transfers by instituting the PLAT protocol or at minimum the fFN collection at outlying
sending facilities.
Conclusion
This was the first study with the focus on evaluating the effectiveness of a
standardized algorithm for triaging preterm labor patients in the upper peninsula of
Michigan. Examined in the retrospective study were 90 pre-implementation preterm
labor patient charts in the 2 years preceding with 91 post-implementation charts in the 2
years after initiation of the protocol. The use of an evidence-based standardized
algorithm in triaging PTL patients was effective in both improving patient outcomes and
in decreasing costs. Hospital admissions decreased by 78%, which resulted in an
estimated $150,000 cost savings. The time of disposition to decision, or time in triage,
decreased from approximately 5 hours to 2.6 hours. This accounted for an estimated
$340,000 in cost savings. When coupled with admission savings, the result was nearly
$500,000 in savings for the hospital over a 2-year period in only a small sample of
patients.
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Patient outcomes improved reflective with less time in triage by a disposition and
diagnosis made quicker with standardized evidence-based diagnostic testing, allowing for
peace of mind. Of patients admitted for preterm labor in post-implementation data, all
were discharged home undelivered from that visit. This included transfer patients sent
from outlying facilities who were automatic admissions with 3-day stays.
Hospitals across the United States can synthesize research included in this study
and others such as the Rose (2010) study at the Mayo Clinic. Outcomes of both studies
provided strong evidence a standardized algorithm for triaging PTL patients improves
patient outcomes and decreases unnecessary costs to hospitals. Preterm births are the
number one cause of infant deaths across the United States and the world. Consistent
implementation of evidence-based protocols such as PLAT can improve patient outcomes
for this population.
It is imperative all healthcare agencies have collaboration, commitments, and
cooperation from administration, physicians, multidiscipline teams, and nurses to
implement standardized algorithms for improved patient outcomes and to become more
fiscally responsible in accruing unnecessary healthcare costs. Next steps should address
implementing a national standardized algorithm that tailored to facilities based on their
resources. Strategies to attain this would involve the comprehensive approach and
advocacy of dedicated individuals to highlight benefits from the latest research such as
this study to national audiences, including government health committees. In the future,
hospitals across the United States should adopt and personalize a standardized algorithm
to triage preterm labor patients efficiently for improved patient outcomes.
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Limitations to the study included the convenience sample of patients. A
limitation in this study was patients were coded with specific ICD-9 and 10 codes for
preterm and threatened preterm labor. The limitation identified in data collection was
that some patients were coded incorrectly and were not preterm labor patients; such
patients were removed from the study. Another limitation to the convenience sample was
transfer patients. Due to the automatic admission and nature of treatment, transfer
patients skewed data from admissions. To garner a true admission percentage, transfer
patients were excluded from the number of admissions.
A final limitation to the study was that transvaginal ultrasounds increased two-
fold and this had the potential to decrease cost savings. Transvaginal ultrasounds can
cost $1,000-$3,000. Even with this limitation, savings to the hospital were identified and
rather remarkable at nearly half a million dollars in 2 years on a fraction of patients
triaged. The clinical measure of transvaginal ultrasound with cervical length allowed
overall for a more definitive diagnosis and discharge sooner for patients, which may
offset the extra cost.
Aside from study limitations, results of this research provided positive assurance
in the effectiveness of a standardized algorithm for PTL patient triage moving forward.
The outcome for patients to have peace of mind with swifter diagnoses and either
discharge or admission and treatment is imperative. Future studies can assess and
measure this qualitative data behind standardized protocols from the patient’s point of
view and experience.
After implementation of the standardized PTL algorithm, patients were triaged faster
and subsequently discharged sooner receiving fewer unnecessary costly interventions if
not high risk for PTB. Patients identified in PTL received treatment earlier to have better
outcomes by stopping or slowing the progression of labor and allowing antenatal
corticosteroid (AS) treatment. The correct timing of AS within 1 week of delivery was
key to their benefit in allowing for fetal lung maturity. Results from a study conducted
by Adams, Kinzler, Chavez, and Vintzileos (2015) revealed 80% of the time patients
receive AS at suboptimal timing. Utilizing evidence-based standardized algorithms, such
as PLAT, increased the potential to improve the timing of AS and the outcomes for
preterm babies.
In the post-implementation group, no preterm deliveries were noted at hospital
visits and all admitted patients were discharged home undelivered. Studies such as Rose
(2010) tracked patients sent home undelivered to assess if they went on to deliver at term.
This was efficient in analyzing the true outcomes of these mothers. In future studies, end
outcomes of the PTL patients can be measured to assess the validity of the
standardization further. For this study, in the immediate triage visit, optimal outcomes
were found including decreased disposition to decision times and less maternal
admissions with resultant increased cost savings. Although preterm birth at times can be
inevitable, in cases where a standardized protocol is followed to diagnose and treat,
improved outcomes are possible in this population.
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References
Adams, T. M., Kinzler, W. L., Chavez, M. R., & Vintzileos, A. M. (2015). The timing of
administration of antenatal corticosteroids in women with indicated preterm birth.
American Journal of Obstetrics and Gynecology, 212(5), 645. e1-4.
https://doi.org/10.1016/j.ajog.2014.11.021
Berghella, V., Hayes, E., Visintine, J., & Baxter, J. K. (2008). Fetal fibronectin testing for
reducing the risk of preterm birth. The Cochrane database of systematic reviews,
(4), CD006843. https://doi.org/10.1002/14651858.CD006843.pub2
Berghella, V., Baxter, J. K., & Hendrix, N. W. (2013). Cervical assessment by ultrasound
for preventing preterm delivery. In Cochrane database of systematic reviews.
John Wiley & Sons, Ltd. Retrieved from
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007235.pub3/abstract
Blackwell, S. C., Sullivan, E. M., Petrilla, A. A., Shen, X., Troeger, K. A., & Byrne, J. D.
(2017). Utilization of fetal fibronectin testing and pregnancy outcomes among
women with symptoms of preterm labor. ClinicoEconomics and Outcomes
Research: CEOR, 9, 585–594. https://doi.org/10.2147/CEOR.S141061
Bolt, L. A., Chandiramani, M., De Greeff, A., Seed, P. T., Kurtzman, J., & Shennan, A.
H. (2011). The value of combined cervical length measurement and fetal
fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk
women. The Journal of Maternal-Fetal & Neonatal Medicine, 24(7), 928–932.
https://doi.org/10.3109/14767058.2010.535872
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Preterm Birth | Maternal and Infant Health | Reproductive Health | CDC. (2017,
December 4). Retrieved April 10, 2018, from
https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm
DeFranco, E. A., Lewis, D. F., & Odibo, A. O. (2013). Improving the screening accuracy
for preterm labor: Is the combination of fetal fibronectin and cervical length in
symptomatic patients a useful predictor of preterm birth? A systematic review.
American Journal of Obstetrics and Gynecology, 208(3), 233. e1-233.e6.
https://doi.org/10.1016/j.ajog.2012.12.015
Institute of Medicine (US) Committee on understanding premature birth and assuring
healthy outcomes. (2007). Preterm Birth: Causes, Consequences, and Prevention.
(R. E. Behrman & A. S. Butler, Eds.). Washington (DC): National Academies
Press (US). Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK11362/
Iyer, S., McElrath, T., Jarolim, P., & Greenberg, J. (2013). The association of fFN testing
on hospital admissions for preterm labor. Open Journal of Obstetrics and
Gynecology, 03(01), 126. https://doi.org/10.4236/ojog.2013.31024
Lucovnik, M., Chambliss, L. R., & Garfield, R. E. (2013). Costs of unnecessary
admissions and treatments for “threatened preterm labor.” American Journal of
Obstetrics and Gynecology, 209(3), 217. e1-217.e3.
https://doi.org/10.1016/j.ajog.2013.06.046
March of Dimes. (2016). Preterm labor assessment toolkit | March of Dimes. Retrieved
from http://www.marchofdimes.org/professionals/preterm-labor-assessment-
toolkit.aspx
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McCue, B., & Torbenson, V. E. (2017, September 15). Fetal fibronectin: The benefits of
a high negative predictive value in management of preterm labor. Retrieved from
http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/fetal-
fibronectin-benefits-high-negative-predictive-value-management-preterm-labor
Michigan Department of Health and Human Services [MDHHS]. (2012). Michigan
focuses on reducing premature births to improve infant mortality rates. Retrieved
from http://www.michigan.gov/mdhhs/0,5885,7-339--289859--,00.html
https://www.michigan.gov/documents/mdch/MichiganIMReductionPlan_393783_
7.pdf
Peaceman, A. M., Andrews, W. W., Thorp, J. M., Cliver, S. P., Lukes, A., Iams, J. D., …
Pietrantoni, M. (1997). Fetal fibronectin as a predictor of preterm birth in patients
with symptoms: a multicenter trial. American Journal of Obstetrics and
Gynecology, 177(1), 13–18.
Rose, C. H., McWeeney, D. T., Brost, B. C., Davies, N. P., & Watson, W. J. (2010).
Cost-effective standardization of preterm labor evaluation. American Journal of
Obstetrics & Gynecology, 203(3), 250.e1-250.e5.
https://doi.org/10.1016/j.ajog.2010.06.037
Slager, J., & Lynne, S. (2012). Assessment of cervical length and the relationship
between short cervix and preterm birth. Journal of Midwifery & Women’s Health,
57(Supplment 1), S4-11. https://doi.org/10.1111/j.1542-2011.2012.00209.x
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Van Baaren, G. J., Vis, J. Y., Grobman, W. A., Bossuyt, P. M., Opmeer, B. C., & Mol, B.
W. (2013). Cost-effectiveness analysis of cervical length measurement and
fibronectin testing in women with threatened preterm labor. American Journal of
Obstetrics and Gynecology, 209(5), 436. e1-8.
https://doi.org/10.1016/j.ajog.2013.06.029
http://www.who.int/mediacentre/factsheets/fs363/en/
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Figure. March of Dimes Preterm Labor Assessment Toolkit Algorithm (2010)
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Figure. Upper Peninsula Regional Hospital and outlying critical care access facilities
Northern Michigan University
Mandi Wilkins
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